Identification of new biological markers for the evaluation of different effects of thyroid hormones on different tissues

Identification of non-responders to levothyroxine-therapy: development of biomarkers reflecting T4 and T3 action at the tissue level

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003673-34-NO

Enrollment

Registered

2018-02-13

Start date

2018-04-05

Completion date

Unknown

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with dysregulated hypothyroidism

Interventions

Trade Name: Liothyronine Product Name: Liothyronine Pharmaceutical Form: Tablet Trade Name: Levaxin Product Name: Levaxin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women with poorly regulated hypothyroidism defined as subjective feeling of cold intolerance, fatigue, cognitive- and memory-related problems despite adequate thyroxine (Levaxin) therapy, age between 18-65 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cardiovascular disease, liver disease, other endocrinological disease (diabetes mellitus Mb. Addison, hypopituitarism), hormonal substitution therapy beyond T4 and T3, psychiatric disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To objectify which patients who will benefit from combination therapy with levaxin and liothyronine, by examining biomarkers reflecting the different hormonal effects on tissue level;Secondary Objective: To assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and quality of life;Primary end point(s): Identification of new biomarkers reflecting the effects of T4 and T3 on cell and tissue level;Timepoint(s) of evaluation of this end point: 01.03.2019	—

Measure

Time frame

Main Objective: To objectify which patients who will benefit from combination therapy with levaxin and liothyronine, by examining biomarkers reflecting the different hormonal effects on tissue level;Secondary Objective: To assess differential effects of T4 and T3 on body temperature, metabolism, muscle strength and quality of life;Primary end point(s): Identification of new biomarkers reflecting the effects of T4 and T3 on cell and tissue level;Timepoint(s) of evaluation of this end point: 01.03.2019

—

Secondary

Measure	Time frame
Secondary end point(s): Mean levels of thyroid hormones secretion Body temperature, metabolism, muscle strength and quality of life Number of patients who prefer monotherapy with Liothyronine ;Timepoint(s) of evaluation of this end point: 01.03.2019	—

Countries

Norway

Contacts

Public ContactErik Fink Eriksen

Oslo University Hospital

e.f.eriksen@medisin.uio.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026